# K112635: U by Kotex Sleek Unscented Menstrual Tampons

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Oct 7, 2011 after 28 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864750 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091749: U by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and Super Plus, Kimberly-Clark Corp. (2009) Summary page 1.

## Recalls of this device
- Dec 11, 2018 · Class II · Z-0750-2019: Potential for tampon to come apart upon removal.
- Dec 11, 2018 · Class II · Z-0748-2019: Potential for tampon to come apart upon removal.
- Dec 11, 2018 · Class II · Z-0749-2019: Potential for tampon to come apart upon removal.
- Dec 11, 2018 · Class II · Z-0751-2019: Potential for tampon to come apart upon removal.

## Indications for use
Kimberly-Clark* U by KOTEX Sleek* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

Source page: https://510kreport.com/device/K112635
Methodology: https://510kreport.com/methodology